FDAFDA · Food and drugs·Recall number Z-0637-2022
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.
Published February 16, 2022 · Recall initiated: March 2, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- International distribution in the countries of Canada and Germany.
- Lot
- Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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